CORXEL Announces Strategic Collaboration Agreement with Grand Pharma

SHANGHAI, China, Dec. 11, 2024 – Corxel Pharmaceuticals (CORXEL), today announced a strategic collaboration agreement with Grand Pharmaceutical Group Limited (“Grand Pharma”) for CORXEL's ophthalmic products, varenicline solution nasal spray, and related ancillary assets. Subject to the fulfillment of the relevant conditions, Grand Pharma will acquire the exclusive rights for the development and commercialization of varenicline solution nasal spray and related ancillary assets in Greater China (Mainland China, Hong Kong Special Administrative Region of China, Macao Special Administrative Region of China, and Taiwan Region), subject to an undisclosed amount of upfront and near-term milestone payments , and additional potential future sales milestones.

Varenicline solution nasal spray is a highly selective cholinergic agonist. It activates the trigeminal parasympathetic pathway resulting in increased production of basal tears to stabilize tear film.  In October 2021, the U.S. FDA approved varenicline solution nasal spray for the treatment of the signs and symptoms of dry eye disease. In November 2024，the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of the PRC has approved the New Drug Application (NDA) for varenicline solution nasal spray to increase tear production in patients with Dry Eye in China, marking the first and only nasal spray approved for the condition in China.

“The recent approval of varenicline solution nasal spray in China marks an important milestone for CORXEL, demonstrating that CORXEL has comprehensive capabilities in clinical development and the registration of innovative medicines. CORXEL's efforts to complete the Phase 3 clinical study quick and with excellent quality, as well as the swift submission of the NDA, all contributed to the drug's rapid approval. At the same time, our partnership with WuXi STA in establishing a local manufacturing facility ensures robust and responsive product supply in China”, said Sandy Mou, Board Executive Director and Chief Executive Officer of CORXEL. “Grand Pharma has deep roots and rich experience in the field of ophthalmic medicine development and commercialization, and we believe that this collaboration will accelerate the broad coverage of varenicline nasal spray in the Chinese market and enable more dry eye patients in China to benefit from this innovative therapy as early as possible.”